Heplisav-B (Dynavax) was approved by the Food and Drug Administration (FDA) in November 2017 for people 18 years of age and older. Heplisav-B contains a novel adjuvant (CpG 1018) that binds to Toll-like receptor 9 to stimulate the immune response to HBsAg. It is provided in a single dose 0.5 mL vial and given as a 2-dose series with doses separated by 1 month (4 weeks).
Heplisav-B was approved based on clinical trials that compared seroprotection rates (SPR, defined as anti-HBs of 10 mIU or higher, and indicative of protection against hepatitis B infection) following 2 doses of Heplisav-B to rates following 3 doses of Engerix-B (GSK). Among people 18 through 70 years of age, SPRs were 90%–95% following 2 doses of Heplisav-B and 65%–81% following 3 doses of Engerix-B. Local reactions were most commonly reported (injection site pain, redness, and swelling) and were similar in frequency to those following Engerix-B.
The package insert for Heplisav-B is available here: www.fda.gov/media/108745/download.